As Human Kapital, on behalf of our corporate client operating in the pharmaceutical industry, we are seeking an International Regulatory Affairs Manager with strong experience in overseas regulatory processes, solid knowledge of global regulations, and proven team management capabilities.

Required Qualifications

• Bachelor’s degree in Pharmacy, Chemical Engineering, Chemistry, or a related field,
• Minimum 10 years of experience in the pharmaceutical industry,
• Prior experience in team management with demonstrated leadership skills,
• Preferably experienced in preparing overseas regulatory submission dossiers in CTD format,
• Strong knowledge of global regulations and international health authorities,
• Familiar with technology transfer processes and R&D (Product Development) activities,
• Advanced level of English,
• Proficient in MS Office applications,
• Strong communication skills and a collaborative team player,
• For male candidates, completion of military service,

Able to reside in Istanbul Ataşehir–Kadıköy area or nearby districts.

Duties and Responsibilities

1. Monitoring and implementing international regulatory requirements of relevant countries’ health authorities,
2. Preparing overseas regulatory submission dossiers in compliance with country-specific requirements and managing the submission process,
3. Following up all post-submission processes until product approval and ensuring internal coordination,
4. Establishing effective communication with relevant health authorities,
5. Preparing packaging mock-ups for products to be marketed abroad in accordance with the local language, and managing and tracking design approval processes,
6. Notifying relevant country authorities of variations and changes made to licensed products,
7. Tracking license renewal processes,
8. Working in close cooperation with the Factory Quality Control unit,
9. Contributing to R&D processes,
10. Following up variation approval processes,
11. Managing and supervising the assigned team.

HUMAN KAPİTAL Human Resources and Consulting Services Industry and Trade Limited Company is a private employment agency operating with the authorization of the Turkish Employment Agency dated 20.06.2025 and numbered 228.
In accordance with Law No. 4904 of the Turkish Employment Agency, no benefit of any kind may be obtained from job seekers.
Charging job seekers any fee is strictly prohibited.